FDA Grants MindMed’s LSD Formulation Breakthrough Designation

The company said it will begin a Phase 3 clinical program in the second half of 2024.

Once demonized as a drug that could scramble chromosomes or lead to insanity,  LSD has shown enough promise in clinical trials to gain breakthrough status for treating generalized anxiety disorder.

Mind Medicine Inc. said March 7 the U.S. Food and Drug Administration granted its MM120 lysergide d-tartrate formulation the designation after a successful Phase 2b study.

The breakthrough status expedites the development and review of drugs that demonstrate significant improvement over current treatments for serious conditions.

MindMed previously reported it achieved a 65% clinical response rate and a 48% clinical remission rate after 12 weeks of administering a single 100-microgram (µg) dose of MM120.

The trial examined 194 participants who were randomized to receive a single administration of MM120 at a dose of 25, 50, 100 or 200 µg or placebo. The 100-µg dose demonstrated the optimal clinical activity.

Study participants experienced mild to moderate adverse events that were temporary, typically occurring on dosing day. The side effects were consistent with expected effects of the drug, including hallucinations, euphoric mood, anxiety, nausea and dizziness.

Prior to treatment, study participants tapered from any anti-anxiety or antidepressant treatments they were previously taking and didn’t receive any study-related psychotherapy during the study period.

Mind Medicine plans to hold a meeting marking the end of the Phase 2 trial with the FDA in the first half of 2024. The company said it will begin a Phase 3 clinical program in the second half of 2024.

Generalized anxiety disorder affects about 10% of U.S. adults, representing around 20 million people. The last new drug approval to treat anxiety occurred in 2004, MindMed noted in its announcement.